Determination That JENLOGA (Clonidine Hydrochloride) Extended-Release Tablets, 0.1 Milligram and 0.2 Milligram, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 7582-7583 [2012-3222]
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7582
Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / Notices
erowe on DSK2VPTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Kristiana Brugger, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6262,
Silver Spring, MD 20993–0002, 301–
796–3601.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA). The only clinical data required
in an ANDA are data to show that the
drug that is the subject of the ANDA is
bioequivalent to the listed drug.
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
KAPVAY (clonidine hydrochloride)
Extended-Release Tablets, 0.2 mg, is the
subject of NDA 22–331, held by
Shionogi Pharma, Inc., and initially
approved on September 28, 2010.
KAPVAY is indicated for the treatment
of attention deficit hyperactivity
disorder as monotherapy or as
adjunctive therapy to stimulant
medications. Shionogi Pharma has
VerDate Mar<15>2010
14:46 Feb 10, 2012
Jkt 226001
never marketed KAPVAY (clonidine
hydrochloride) Extended-Release
Tablets, 0.2 mg. In previous instances
(see, e.g., 72 FR 9763, March 5, 2007; 61
FR 25497, May 21, 1996), the Agency
has determined that, for purposes of
§§ 314.161 and 314.162, never
marketing an approved drug product is
equivalent to withdrawing the drug
from sale.
Actavis, Inc. submitted a citizen
petition dated April 20, 2011 (Docket
No. FDA–2011–P–0292), under 21 CFR
10.30, requesting that the Agency
determine whether KAPVAY (clonidine
hydrochloride) Extended-Release
Tablets, 0.2 mg, was withdrawn from
sale for reasons of safety or
effectiveness.
After considering the citizen petition
and reviewing Agency records, and
based on the information we have at this
time, FDA has determined under
§ 314.161 that KAPVAY (clonidine
hydrochloride) Extended-Release
Tablets, 0.2 mg, was not withdrawn
from sale for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that KAPVAY (clonidine
hydrochloride) Extended-Release
Tablets, 0.2 mg, was withdrawn from
sale for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of KAPVAY
(clonidine hydrochloride) ExtendedRelease Tablets, 0.2 mg from sale. We
have found no information that would
indicate that this product was
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, FDA will continue to list
KAPVAY (clonidine hydrochloride)
Extended-Release Tablets, 0.2 mg, in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. ANDAs that refer
to KAPVAY (clonidine hydrochloride)
Extended-Release Tablets, 0.2 mg, may
be approved by the Agency as long as
they meet all other legal and regulatory
requirements for the approval of
ANDAs. If FDA determines that labeling
for this drug product should be revised
to meet current standards, the Agency
will advise ANDA applicants to submit
such labeling.
Dated: February 7, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–3223 Filed 2–10–12; 8:45 am]
BILLING CODE 4160–01–P
PO 00000
Frm 00018
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–P–0291]
Determination That JENLOGA
(Clonidine Hydrochloride) ExtendedRelease Tablets, 0.1 Milligram and 0.2
Milligram, Were Not Withdrawn From
Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
that JENLOGA (clonidine
hydrochloride) Extended-Release
Tablets, 0.1 milligram (mg) and 0.2 mg,
were not withdrawn from sale for
reasons of safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for clonidine
hydrochloride extended-release tablets,
0.1 mg and 0.2 mg, if all other
requirements are met.
FOR FURTHER INFORMATION CONTACT:
Kristiana Brugger, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6262,
Silver Spring, MD 20993–0002, 301–
796–3601.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products approved
under an ANDA procedure. ANDA
applicants must, with certain
exceptions, show that the drug for
which they are seeking approval
contains the same active ingredient in
the same strength and dosage form as
the ‘‘listed drug,’’ which is a version of
the drug that was previously approved.
ANDA applicants do not have to repeat
the extensive clinical testing otherwise
necessary to gain approval of a new
drug application (NDA). The only
clinical data required in an ANDA are
data to show that the drug that is the
subject of the ANDA is bioequivalent to
the listed drug.
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
SUMMARY:
E:\FR\FM\13FEN1.SGM
13FEN1
erowe on DSK2VPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / Notices
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
JENLOGA (clonidine hydrochloride)
Extended-Release Tablets, 0.1 mg and
0.2 mg, are the subject of NDA 22–331,
held by Shionogi Pharma, Inc., initially
approved on September 29, 2009.
JENLOGA is indicated for the treatment
of hypertension. Shionogi Pharma has
never marketed JENLOGA (clonidine
hydrochloride) Extended-Release
Tablets, 0.1 mg and 0.2 mg. In previous
instances (see, e.g., 72 FR 9763, March
5, 2007; 61 FR 25497, May 21, 1996), the
Agency has determined that, for
purposes of §§ 314.161 and 314.162,
never marketing an approved drug
product is equivalent to withdrawing
the drug from sale.
Actavis, Inc. submitted a citizen
petition dated April 20, 2011 (Docket
No. FDA–2011–P–0291), under 21 CFR
10.30, requesting that the Agency
determine whether JENLOGA (clonidine
hydrochloride) Extended-Release
Tablets, 0.1 mg and 0.2 mg, were
withdrawn from sale for reasons of
safety or effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that JENLOGA (clonidine
hydrochloride) Extended-Release
Tablets, 0.1 mg and 0.2 mg, were not
withdrawn from sale for reasons of
safety or effectiveness. The petitioner
has identified no data or other
information suggesting that JENLOGA
(clonidine hydrochloride) ExtendedRelease Tablets, 0.1 mg and 0.2 mg,
were withdrawn from sale for reasons of
safety or effectiveness. We have
carefully reviewed our files for records
concerning the withdrawal of JENLOGA
(clonidine hydrochloride) ExtendedRelease Tablets, 0.1 mg and 0.2 mg,
from sale. We have found no
information that would indicate that
these products were withdrawn from
VerDate Mar<15>2010
14:46 Feb 10, 2012
Jkt 226001
sale for reasons of safety or
effectiveness.
Accordingly, FDA will continue to list
JENLOGA (clonidine hydrochloride)
Extended-Release Tablets, 0.1 mg and
0.2 mg, in the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ delineates, among other items,
drug products that have been
discontinued from marketing for reasons
other than safety or effectiveness.
ANDAs that refer to JENLOGA
(clonidine hydrochloride) ExtendedRelease Tablets, 0.1 mg and 0.2 mg, may
be approved by the Agency as long as
they meet all other legal and regulatory
requirements for the approval of
ANDAs. If FDA determines that labeling
for this drug product should be revised
to meet current standards, the Agency
will advise ANDA applicants to submit
such labeling.
Dated: February 7, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–3222 Filed 2–10–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–P–0701]
Determination That WILPO
(phentermine hydrochloride) Tablets, 8
Milligrams, Was Not Withdrawn From
Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
that WILPO (phentermine
hydrochloride) Tablets, 8 Milligrams
(mg), was not withdrawn from sale for
reasons of safety or effectiveness. This
determination will allow FDA to
approve Abbreviated New Drug
Applications (ANDAs) for phentermine
hydrochloride tablets, 8 mg, if all other
legal and regulatory requirements are
met.
FOR FURTHER INFORMATION CONTACT: Nam
Kim, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 6320, Silver Spring,
MD 20993–0002, 301–796–3472.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
SUMMARY:
PO 00000
Frm 00019
Fmt 4703
Sfmt 4703
7583
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA). The only clinical data required
in an ANDA are data to show that the
drug that is the subject of the ANDA is
bioequivalent to the listed drug.
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
WILPO (phentermine hydrochloride)
Tablets, 8 mg is the subject of NDA
012737, held by Sandoz, Inc. WILPO is
indicated in the management of
exogenous obesity as a short term
adjunct (a few weeks) in a regimen of
weight reduction based on caloric
restriction.
WILPO (phentermine hydrochloride)
Tablets, 8 mg, is currently listed in the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
KVK–Tech, Inc. (KVK–Tech),
submitted a citizen petition dated
September 22, 2011 (Docket No. FDA–
2011–P–0701), under 21 CFR 10.30,
requesting that the Agency determine
whether WILPO (phentermine
hydrochloride) Tablets, 8 mg, was
withdrawn from sale for reasons of
safety or effectiveness. After considering
the citizen petition and reviewing
E:\FR\FM\13FEN1.SGM
13FEN1
]]>Agencies
[Federal Register Volume 77, Number 29 (Monday, February 13, 2012)]
[Notices]
[Pages 7582-7583]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-3222]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-P-0291]
Determination That JENLOGA (Clonidine Hydrochloride) Extended-
Release Tablets, 0.1 Milligram and 0.2 Milligram, Were Not Withdrawn
From Sale for Reasons of Safety or Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined that
JENLOGA (clonidine hydrochloride) Extended-Release Tablets, 0.1
milligram (mg) and 0.2 mg, were not withdrawn from sale for reasons of
safety or effectiveness. This determination will allow FDA to approve
abbreviated new drug applications (ANDAs) for clonidine hydrochloride
extended-release tablets, 0.1 mg and 0.2 mg, if all other requirements
are met.
FOR FURTHER INFORMATION CONTACT: Kristiana Brugger, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6262, Silver Spring, MD 20993-0002, 301-
796-3601.
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
applicants must, with certain exceptions, show that the drug for which
they are seeking approval contains the same active ingredient in the
same strength and dosage form as the ``listed drug,'' which is a
version of the drug that was previously approved. ANDA applicants do
not have to repeat the extensive clinical testing otherwise necessary
to gain approval of a new drug application (NDA). The only clinical
data required in an ANDA are data to show that the drug that is the
subject of the ANDA is bioequivalent to the listed drug.
The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,''
[[Page 7583]]
which is known generally as the ``Orange Book.'' Under FDA regulations,
drugs are removed from the list if the Agency withdraws or suspends
approval of the drug's NDA or ANDA for reasons of safety or
effectiveness or if FDA determines that the listed drug was withdrawn
from sale for reasons of safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale but
must be made prior to approving an ANDA that refers to the listed drug
(Sec. 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does
not refer to a listed drug.
JENLOGA (clonidine hydrochloride) Extended-Release Tablets, 0.1 mg
and 0.2 mg, are the subject of NDA 22-331, held by Shionogi Pharma,
Inc., initially approved on September 29, 2009. JENLOGA is indicated
for the treatment of hypertension. Shionogi Pharma has never marketed
JENLOGA (clonidine hydrochloride) Extended-Release Tablets, 0.1 mg and
0.2 mg. In previous instances (see, e.g., 72 FR 9763, March 5, 2007; 61
FR 25497, May 21, 1996), the Agency has determined that, for purposes
of Sec. Sec. 314.161 and 314.162, never marketing an approved drug
product is equivalent to withdrawing the drug from sale.
Actavis, Inc. submitted a citizen petition dated April 20, 2011
(Docket No. FDA-2011-P-0291), under 21 CFR 10.30, requesting that the
Agency determine whether JENLOGA (clonidine hydrochloride) Extended-
Release Tablets, 0.1 mg and 0.2 mg, were withdrawn from sale for
reasons of safety or effectiveness.
After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec. 314.161 that JENLOGA (clonidine hydrochloride) Extended-
Release Tablets, 0.1 mg and 0.2 mg, were not withdrawn from sale for
reasons of safety or effectiveness. The petitioner has identified no
data or other information suggesting that JENLOGA (clonidine
hydrochloride) Extended-Release Tablets, 0.1 mg and 0.2 mg, were
withdrawn from sale for reasons of safety or effectiveness. We have
carefully reviewed our files for records concerning the withdrawal of
JENLOGA (clonidine hydrochloride) Extended-Release Tablets, 0.1 mg and
0.2 mg, from sale. We have found no information that would indicate
that these products were withdrawn from sale for reasons of safety or
effectiveness.
Accordingly, FDA will continue to list JENLOGA (clonidine
hydrochloride) Extended-Release Tablets, 0.1 mg and 0.2 mg, in the
``Discontinued Drug Product List'' section of the Orange Book. The
``Discontinued Drug Product List'' delineates, among other items, drug
products that have been discontinued from marketing for reasons other
than safety or effectiveness. ANDAs that refer to JENLOGA (clonidine
hydrochloride) Extended-Release Tablets, 0.1 mg and 0.2 mg, may be
approved by the Agency as long as they meet all other legal and
regulatory requirements for the approval of ANDAs. If FDA determines
that labeling for this drug product should be revised to meet current
standards, the Agency will advise ANDA applicants to submit such
labeling.
Dated: February 7, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-3222 Filed 2-10-12; 8:45 am]
BILLING CODE 4160-01-P
